Vial adapter for drawing drugs from a vial

ABSTRACT

A vial adapter for reconstituting a drug and drawing a drug from a vial. The vial adapter includes a passageway for passage of a diluent into the vial to mix with and reconstitute the drug and a chamber containing the reconstituted drug drawn from the vial. A vacuum is applied through the adapter to draw the reconstituted drug from the vial. The reconstituted drug can be accessed in one or two ways, either via a luer locked syringe or via a needled syringe.

This application claims priority from provisional application Ser. No.62/812,870, filed Mar. 1, 2019, the entire contents of which areincorporated herein by reference.

BACKGROUND Technical Field

This application relates to a vial adapter for cosmetics and otherinjectables, and, more particularly, to a vial adapter for drawing adrug from a vial.

Background of Related Art

Botulinum toxin is a neurotoxin made from a toxin produced by thebacterium Clostridium botulinum. Doctors use this drug in small doses incosmetics for temporary smoothing of facial wrinkles and improvingappearance as it causes relaxation of muscles resulting in smoothing ofthe overlying skin. Common types of botulinum toxin used for cosmeticsare Botox (sold by Allergan, Dysport/Azzalure and Xeomin.

Currently, reconstitution of neurotoxins has to be performed beforeinjection. FDA approved neurotoxins on the market are freeze dried(Dysport) or vacuum dried (Botox), and thus saline needs to be added tothe neurotoxin vial. The process of reconstitution and drawing upneurotoxin is currently delegated—dermatologists have medical assistantsassigned to this process. If the assistants are not trained properly onreconstitution, there can be inconsistency of results (due to impropermixing) leading to patient complaints of the longevity of treatment.Additionally, if the assistants are not trained properly on drawing uptoxin from the vial after reconstitution, there can be a significantloss in revenue due to the expense of this medication. In fact, in somecases, hundreds of dollars of toxin can be left over in the vials if thetoxin is not properly drawn. Moreover, many providers will uncap toxinvials to access the remaining toxin solution in the vial to avoid any ofthe expensive drug being left behind and wasted. This affects thesterility of the contents and the possibility of pieces of the rubberstopper entering this toxin/saline solution and being drawn back intothe injecting syringe.

Thus, the current methodologies of reconstitution and subsequentinjection of botulinum toxin (or other neuromodulators) are inconsistentand inefficient. Prolonged amounts of time required, loss of byproductwithin the vial, and issues with sterility are just a few of thedrawbacks of the current methods.

Therefore, the need exists for an improved device and method forreconstitution and drawing of neurotoxin to address the drawbacks of thecurrent devices and methods. Such improved devices and methods couldalso be utilized for other injectables suffering similar drawbacks.

SUMMARY OF THE INVENTION

The present invention overcomes the problems and deficiencies of theprior art. The present invention provides vial adapters that remedy theinefficiencies of current methods of drawing up neurotoxin. The vialadapters of the present invention enable easier access to theneurotoxin, maintain proper sterility and minimize waste of theneurotoxin. In some embodiments, the vial adapters of the presentinvention further produce a superior neuromodulator product that is moreefficiently reconstituted, i.e., it speeds up the current practice ofreconstitution. Various embodiments of the vial adapters are discussedbelow.

In accordance with one aspect of the present invention, a vial adapterfor reconstituting a drug and drawing a drug from a vial is providedincluding a passageway for passage of a liquid (diluent) into the vialto mix with and reconstitute the drug and a chamber containing thereconstituted drug drawn from the vial. A vacuum is applied through theadapter to draw the reconstituted drug from the vial.

In some embodiments, the vial adapter includes a first portcommunicating with the chamber to provide access for a syringe to applythe vacuum to draw the reconstituted drug.

In some embodiments, the chamber stores the reconstituted drug and isaccessible to withdraw the reconstituted drug therefrom for injection ina patient.

In some embodiments, the passageway is formed in a needle extendingwithin the adapter, the needle having a penetrating tip with an openingfor passage of the liquid into the vial.

In some embodiments, the vial adapter includes a second port incommunication with the passageway, the second port receiving a syringefor inserting the liquid through the adapter and into the vial.

In some embodiments, the vial adapter includes a filter blocking accessof the particles from the vial into the chamber.

In accordance with another aspect of the present invention, a vialadapter for drawing a drug from a vial is provided, the vial adapterincluding a needle having a penetrating tip for accessing an internalchamber of the vial containing the drug and a chamber proximal of thepenetrating tip, the chamber providing access for an injection needle towithdraw the drug. A filter separates the chamber to prevent particlesfrom the vial entering into the chamber through the filter.

In some embodiments, the chamber provides a space for mixing of adiluent with the drug from the vial to reconstitute the drug within thechamber.

In some embodiments, the needle forms a vacuum for drawing the drug intothe chamber.

In some embodiments, the chamber includes one or both of a) a membranepenetrable by an injection syringe; and b) an access port for aninjection needle.

In accordance with another aspect of the present invention, a method forreconstituting a drug for subsequent injection into a patient isprovided. The method comprising the steps of a) inserting a penetratingtip of a needle of a vial adapter into a vial containing a drug, thevial adapter connected to the vial; b) passing a diluent through apassageway in the adapter for entry into the vial to mix with andreconstitute the drug; and c) drawing the reconstituted drug from thevial into a chamber of the adapter.

In some embodiments, the reconstituted drug is drawn from the chamberfor injection of the drug into a patient by an injection device.

In some embodiments, the diluent is passed through a passageway in theneedle.

In some embodiments, the step of drawing the reconstituted drug from thevial includes applying a vacuum through the vial adapter. In someembodiments, the step of applying a vacuum applies a vacuum through thepassageway in the vial adapter. The passageway in some embodiments canbe through the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a Dysport 300 u vial (bottle) of theprior art, the circle highlighting a cored piece of rubber that couldpotentially be drawn into an injecting syringe;

FIG. 2 is a cross-sectional view of one embodiment of the vial adapterof the present invention;

FIG. 3 is a perspective view of an alternate embodiment of the needle ofthe vial adapter of FIG. 2 ;

FIG. 4 is a cross-sectional view of an alternate embodiment of the vialadapter of the present invention having a channel for reconstitution;

FIG. 5A is a perspective view of a vial (bottle) of the prior artcontaining a neurotoxin;

FIG. 5B is a perspective view of an alternate embodiment of the vialadapter of the present invention shown attached to the vial of FIG. 5A;

FIG. 6 is a perspective view showing saline in the collection chamber ofthe adapter of FIG. 5B and flowing into the neurotoxin vial;

FIG. 7 is a perspective view showing the vial adapter of FIG. 6 invertedand the saline and neurotoxin solution collected in the collectionchamber of the vial adapter;

FIG. 8 is a perspective view of an alternate embodiment of the vialadapter of the present invention shown attached to the neurotoxin vialof FIG. 5A;

FIG. 9 is a perspective view similar to FIG. 8 showing two differentdevices which can be inserted into the chamber of the vial adapter toload the collection chamber with saline;

FIG. 10 is a perspective view of the vial adapter of FIG. 9 inverted andthe saline and neurotoxin solution collected in the collection chamberof the vial adapter;

FIG. 11 is a perspective view showing the vial syringe and the vialadapter of FIG. 2 separated;

FIG. 12 is a perspective view of an alternate embodiment of the vialadapter of the present invention shown attached to a vial of neurotoxin;

FIG. 13 is an exploded view of the vial adapter of FIG. 12 shown priorto attachment to the neurotoxin vial;

FIG. 14A is a cross-sectional view of the vial adapter attached to aneurotoxin vial of FIG. 13 and further showing a syringe being insertedinto a top port of the vial adapter of the present invention;

FIG. 14B is a view similar to FIG. 14A showing a syringe being insertedinto a side port of the vial adapter; and

FIG. 15 is a cross-sectional view of an alternate embodiment of the vialadapter attached to a neurotoxin vial of FIG. 13 .

DESCRIPTION OF PREFERRED EMBODIMENTS

Botulinum toxin is a neurotoxin used in small doses in cosmetics fortemporary smoothing of facial wrinkles and improving appearance as itcauses relaxation of muscles resulting in smoothing of the overlyingskin. Before use, the botulinum toxin needs to be reconstituted by theaddition of saline. After reconstitution, the toxin is drawn up from thevial for injection into the patient. Proper mixing of the saline withthe toxin is required to achieve desired results. Also, due to theexpense of the toxin, leaving toxin behind in the vial adds unnecessaryexpense. Additionally, in trying to retrieve all the toxin from thevial, sterility should be maintained for patient safety.

The present invention provides a vial adapter that enables easier accessto the neurotoxin in a vial, maintains proper sterility and minimizeswaste of the neurotoxin.

In some embodiments, the vial adapters of the present invention furtherproduce a superior neuromodulator product that is more efficientlyreconstituted, i.e., it speeds up reconstitution and improves theconsistency of the saline toxin solution.

Various embodiments of the vial adapter of the present invention arediscussed below. Before discussing the vial adapters of the presentinvention, the steps in the current process of reconstitution anddrawing up neurotoxin will first be discussed. Note the current processis typically performed by medical assistants, and is tedious andinefficient as well as results in inconsistency, prolonged treatment andadded expense.

The steps currently required for drawing up neurotoxin are as follows:

-   -   1) Use an 18 g needled-syringe with bacteriostatic saline to        reconstitute toxin with desired dilution amount.    -   2) Switch to a 29 g or smaller needled syringe to draw up        desired units of toxin from the vial for injection into the        patient (FIG. 1 shows a standard vial designated by letter V).    -   3) When the reconstituted vial comes to a low solution amount,        decap the vial's metallic cap with a bottle opener to permit a        needled-syringe access to the remainder of toxin.    -   4) Use a needled syringe to scrape the bottom of the vial to        draw whatever toxin is left in the vial.    -   5) The remaining solution is then added to a newly reconstituted        Toxin vial.

There are several disadvantages associated with each of the foregoingfive steps of this process which are noted below, with the numbered list1-5 below corresponding to the process steps 1-5 above:

-   -   1) The 18 g needled-syringe for reconstitution is discarded,        adding medical waste.    -   2) The needle (≤29 g) for drawing up toxin will easily dull by        having to penetrate through the thick rubber stopper on the        vial, such dulling causing discomfort for the patient during        injections and increasing the tendency for bruising.    -   3) Small cored bits of the rubber stopper can enter the solution        that could be drawn into the injecting needled-syringe. This        creates the potential for intravascular injection of rubber        stopper pieces which can cause infection if injected into the        skin or vascular system. Further, due to capillary action on the        toxin vial, this step is tedious. The vial must be tipped to        allow remaining toxin to collect in order to be drawn up, and        somewhere about 5% to about 8% of the toxin remains in the vial        which adds to expense since it could represent as much as a $50        loss per vial if this step is not done correctly.    -   4) The needle syringe used to scrape the bottom of the vial to        draw whatever toxin is left is discarded, resulting in medical        waste.    -   5) If the remaining solution is added to a newly reconstituted        toxin vial, the solution has technically been contaminated and        is being added to another single-use vial, resulting in        non-sterility.

The present invention provides a device and method to overcome theforegoing drawbacks. The present invention provides a vial adapter whichis attachable (connectable) to a vial containing the neurotoxin. Notethat although the vial adapters described herein are used for cosmeticinjectables, such as a neuromodulator, like botulinum toxin types A orB. such as Dysport or Botox, it should be appreciated that otherinjectables are also contemplated for use with the adapters of thepresent invention, such as deoxycholic acid, polidocanol, poly-L lacticacid solution, and kenalog by way of example. The vial adapter of thepresent invention is attached by the user to the medicine (drug) vial.

In some embodiments the vial adapter is dual vented to enable dilutionof toxin in its chamber. In some embodiments, it uses pressuredifferentials to vacuum all the toxin from the vial into the collectingchamber of the adapter, permitting the user to draw up the toxindirectly into the needled syringe for injection. In other embodiments,the vial adapter is dual vented and facilitates dilution of toxin in thevial itself. These various embodiments are discussed in detail below.

The vial adapter can also include in some embodiments a filter toprevent cored pieces from the rubber stopper of the vial from beingdrawn up. Thus, the filter prevents any microscopic matter, such assmall pieces of rubber stopper, which are often cored into the solutionupon reconstitution with a large-bore needle, to be safely removed fromthe neuromodulator. This purifies the solution thereby maintaining thequality of the product prior to it being drawn up and then injected intothe skin.

Turning now to the drawings wherein like reference numerals identifysimilar or like components throughout the several views, severalembodiments of the vial adapter of the present invention areillustrated.

With initial reference to FIG. 2 , the vial adapter of this embodimentis designated generally by reference numeral 10 and includes a spike orneedle 12 with a penetrating tip 16 at the distal end and a collectionchamber 18 at the proximal end. The collection chamber 18 is definedwithin outer wall 19 and can be of various shapes/dimensions, one suchconfiguration shown in FIG. 2 . The adapter 10 includes a base or flange26 for abutment with the top of the vial (bottle) containing theneurotoxin. The needle 12 has a plurality of fenestrations (holes) 14along a length formed in its outer wall shown in a staggeredarrangement. The number of fenestrations 14 can vary and the number offenestrations shown in FIG. 2 is one example of the number andarrangement of fenestrations as other numbers and/or arrangements (e.g.,non-staggered) of fenestrations are also contemplated. FIG. 3illustrates another embodiment of the needle designated by referencenumeral 30, having six fenestrations 32 along its length with three onopposing sides of the circumference of the outer wall and staggered. Theneedle 30 also has a pointed conical penetrating tip 34 which is adifferent configuration than the beveled pointed penetrating tip of theneedle of FIG. 2 .

Turning back to FIG. 2 , the piercing needle 12 is configured to piercethe rubber stopper on the drug, e.g., neurotoxin, vial (also referred toherein as the bottle), an example of the vial V shown in FIG. 1 . Theneurotoxin is contained in the bottle under vacuum. The length and widthof the needle 12 can vary, however, preferably it is just long enough toreach through the neck of the drug vial and the gauge wide enough todraw toxin in efficiently. In some embodiments by way of example, thelength of the needle is between about 0.5 inch to about 1.0 inch and thegauge is between about 18 g and about 22 g, although other dimensionsare also contemplated.

The multiple staggered fenestrations 14 (and 32 in the FIG. 3embodiment) form a microscopic vent to create venting so that when thevial V is inverted, all the toxin is vacuum drawn into the adapter 10more easily. That is, the holes 14 create a pressure differentialbetween the vial V and the collection chamber 18 creating a vacuum andpreventing leakage of the drug, e.g. neurotoxin. The fenestrated needle12 thereby acts as a sieve when the vial is inverted and drawing uptoxin. (As noted above, the toxin is contained in the bottle undervacuum). The integrated filter 20, positioned at a distal end of thecollection chamber 18, adjacent base 26, prevents pieces of the coredrubber stopper of the vial V or other particulates from being drawn upinto the collection chamber 18, i.e., prevents particulates fromentering the collection chamber 18 when drawing in toxin into thechamber 18. Various types of filters can be utilized. One example whichcan be used is a 5-25 micron filter. Materials which can be used for thefilter include by way of example, nylon, polyester, PVP, etc.

A resealable piercing membrane 24 is positioned within the collectionchamber 18, illustratively at a proximal end, extending transverselywith respect to a longitudinal axis of adapter 10. The membrane 24 isconfigured so that an injection needle or needled syringe can beinserted through the membrane 24 to access the chamber 18 where thereconstituted toxin has been pulled into (stored/contained) and pulls todraw up the toxin therefrom for injection into the patient. The membrane24 is formed so it is sufficiently thin on one hand so as not to dullthe needled syringe inserted therethrough, while sufficiently thick onthe other hand so that multiple piercings by the needled syringe won'tcause any leakage. The membrane 24 can be formed of various materialssuch as silicone, polyurethane, rubber, elastomer, etc. Note themembrane 24 forms a seal to prevent escape of the toxin from the chamber18 except through a piercing needle or syringe inserted through themembrane 24.

In alternate embodiments, the vial adapter provides a bi-directionalfunction to enable reconstitution of the neurotoxin and drawing of theneurotoxin into the chamber for subsequent access and injection into thepatient. Several approaches to reconstituting the neurotoxin of the vial(bottle) are disclosed: in one approach, saline is contained within achamber in the vial adapter and the toxin is drawn into the chamber ofthe vial adapter for mixing; in another approach, the saline iscontained within a chamber in the vial adapter and injected into thevial for mixing with the toxin and then drawn into the chamber of thevial adapter. In another approach, the saline is injected through apassage in the vial adapter to mix with the toxin in the vial and thendrawn through the vial adapter directly into a syringe or into thechamber of the vial adapter.

FIG. 4 illustrates a vial adapter wherein saline from a collectionchamber of the adapter is transferred to the vial (bottle) to dilute(reconstitute) the toxin, and the reconstituted toxin is subsequentlytransferred to the collection chamber. This is achieved by the internalinjection cannula.

More specifically, the vial adapter of FIG. 4 is designated generally byreference numeral 40 and has needle 42 with a lumen 43, a penetratingbeveled tip 46 at the distal end and a collection chamber 48 at theproximal end. The collection chamber 48 is defined within outer wall 49and can be of various shapes/dimensions, one such configuration shown inFIG. 4 . The adapter 40 can include a base or flange 56. The needle 42,like needle 12 of FIG. 2 , has a plurality of fenestrations 44 along alength formed in its outer wall, shown as staggered by way of example.The number of fenestrations 44 can vary and the arrangement of thefenestrations 44 can vary. Thus, the number of fenestrations shown inFIG. 4 is one example of the number and arrangement of fenestrations asother numbers and/or arrangements of fenestrations are alsocontemplated.

The piercing needle 42 is configured to pierce the rubber stopper on themedicine, e.g., neurotoxin, vial (bottle), such as the neurotoxin vialof FIG. 1 . The length and width of the needle 42 can vary, and can insome embodiments be dimensioned as in needle 12 described above.

The multiple staggered fenestrations 44 form a microscopic vent tocreate venting so that when the vial V is inverted, all the toxin isvacuum drawn into the adapter 40 more easily, the fenestrations 44creating a pressure differential between the vial V and the collectionchamber 48 creating a vacuum and preventing leakage of the drug, e.g.neurotoxin. Note a vacuum source, e.g., a syringe, can also be appliedto create a pressure differential between the vial and adapter 40 (andother adapters disclosed herein, e.g., vial adapter 40′), to draw thereconstituted toxin into the chamber of the adapter. A filter 50, likefilter 20, is positioned at a distal end of the collection chamber 48,adjacent base 56, and prevents pieces of the cored rubber stopper of thevial V from being drawn up into the collection chamber 48. Various typesof filters and materials can be utilized as in filter 20 describedabove.

A resealable transversely extending piercing membrane 54, similar tomembrane 24, is positioned within the collection chamber 48 at aproximal end so that an injection needle or needled syringe can beinserted through the membrane 54 to access the chamber 48 where thereconstituted toxin is pulled into and pulls to draw up the toxintherefrom for injection into the patient.

Vial adapter 40 differs from vial adapter 10 in that it has an injectioncannula 58 positioned within the needle 42, illustratively concentricwith the needle 42. Cannula 58 is dimensioned to be positioned withinthe needle 42, preferably concentrically, with a distal tip 62 andopening 59 extending distally of the distal edge 47 of needle 42.Injection cannula 58 includes a lumen 60 and has a suction cannula port64. Thus, this embodiment differs from the embodiment of FIG. 2 in thatsaline is transferred from the collection chamber 48 of the adapter 40into the vial for reconstitution. This difference will be understood inconjunction with the discussion of the method of use below and FIGS. 5-9. Note like vial adapter 10, the reconstituted toxin is transferred(drawn) from the vial to the collection chamber 48. Note the vialadapter 40 can also be used with the side port system of FIG. 14Adiscussed below.

Note in alternate embodiments, the toxin can be drawn from the vial andreconstituted within the collection chamber containing saline.

FIG. 11 illustrates the components for using adapter 40 to draw toxininto the chamber and inject the toxin. The steps for use are asfollows: 1) insert the vented needle 42 into the vial stopper 100 a ofvial 100; 2) inject saline into the collection chamber of the vialadapter by inserting a syringe into the resealable membrane of the vialadapter 40; 3) draw the saline into the vial 100 (via vacuum); and 4)shake the vial 100 to reconstitute. Next, invert the vial 100 (as shownin FIG. 11 ) and draw toxin into the adapter 40 where it pools in thereceiving chamber 48 of adapter 40. Next, draw up reconstituted toxinfrom the chamber with a needle or injecting syringe 98 to a desiredamount for injection into the patient. The vial adapter can duringdrawing of the toxin be returned to its non-inverted orientation.

Turning now to FIGS. 513-7 these Figures illustrate the use of the vialadapter 40′ of the present invention. The vial adapter shown is the vialadapter 40′ which is the same as vial adapter 40 except for the luerlock access described below and thus for convenience the same parts havebeen labeled with the same reference numerals. In FIG. 5B, adapter 40′is shown with base 56 resting on the top (cap) of the vial V to providea stop for insertion of the needle 42. The adapter 40′, like the otheradapters of the present invention disclosed herein, can be eitherremovably or permanently affixed to the vial. If permanently fixed tothe vial, it prevents the user from combining the remaining (unused)neurotoxin with another vial of neurotoxin. The collection chamber 48 atthis point of attachment to the vial 100 is empty as neither saline forreconstitution nor toxin have been injected or drawn into the chamber48. As noted above, the saline is pulled from the collection chamber 48through the needle 42, e.g., a 22 g needle, into the vial V duringreconstitution due to the vacuum in the vial. Adapter 40′ as shown hastwo ways to access the collection chamber 48: 1) needled syringe accessthrough the resealable membrane 54 (e.g., a needled syringe from 19gauge to 32 gauge); or 2) luer lock syringe access through transverselyextending luer lock 70 for non-needled access to the chamber (e.g., aluer accessed port for the syringe). Other ways to access through portsor openings in the chamber are also contemplated.

Thus, the user is provided with two options to access the chamber ofadapter 40′. The re-sealable membrane can allow fine needles, even a 32insulin needle gauge, to pierce through without dulling of the injectingneedle.

For reconstitution, and with reference to FIG. 6 , the collectionchamber 48 of the vial 40′ is first filled with the desired dilutionamount. Note the chamber 48 can be fully filled or partially filled withthe dilution fluid (diluent). In one way, this is achieved by insertionof a needled syringe through membrane 54. In another way, this isachieved by insertion of a luer lock syringe through luer lock 70. Afterfilling the collection chamber 48 with the diluent, the needle 42pierces the rubber stopper of the toxin vial 100 and the dilution liquidis pulled by vacuum of the vial through the needle cannula 58 into thetoxin in the vial 100. The fluid, e.g., saline, for reconstitution, isshown schematically in the chamber 48 and vial 100 and designated byreference numeral 102.

Next, to draw up the reconstituted neurotoxin, as shown in FIG. 7 , thevial 100 is inverted and the toxin solution bathes the staggeredports/vents 44 allowing the toxin to be pulled into the collectionchamber 48. As noted above, the filter 50 prevents particulates fromentering the collection chamber when drawing up toxin. After pulling theneurotoxin into the collection chamber 48, the needle 42 is removed fromthe vial and the neurotoxin in the collection chamber is now ready forwithdrawal and injection into a patient.

FIGS. 8-10 illustrate the method utilizing an alternate embodiment ofthe vial adapter. Vial adapter 80 has a filter 86 (like filter 50), afenestrated needle 82 with holes 84 and latch 88 attachable to the capof the vial. In this embodiment, the latch 88 non-removably latches ontothe neck of the vial for one time use. Alternatively it could beremovably attached to the vial. Various ways to attach the vial adapter80 (as well as the other adapters disclosed herein) other than a latchare also contemplated.

The fenestrated needle 82 functions as described above to create avacuum for drawing up the neurotoxin. Saline is pulled from thecollection chamber 90 through the needle 82 into the vial duringreconstitution. Collection chamber 90, like chamber 48 of FIG. 5 ,provides two ways to access the chamber 90: 1) needled access throughthe resealable membrane 92; or 2) luer lock syringe access throughangled luer lock 94 for non-needled access to the chamber 90. The luerlock access 94 can in this embodiment (and in FIG. 5 and the otherFigures) be capped. The luer lock access 94 in this embodiment is shownangled with a respect to the longitudinal axis of the adapter but couldbe positioned at other angles including a 90 degree angle as in theembodiment of FIG. 5 . The other luer lock accesses and membrane accessof the other embodiments disclosed herein can also be positioned atangles other than those shown.

The collection chamber 90, like chamber 48, provides for loading ofsaline for reconstitution therein and for withdrawal of reconstitutedtoxin therefrom. In some embodiments, the chamber 90 can be configuredto hold 3 cc of total volume, however, other volumes are alsocontemplated as are larger or smaller chambers to hold differentvolumes. The collection chambers of the other vial adapters disclosedherein can also be configured to hold a volume of 3 cc or other volumes.

FIG. 9 illustrates using either a syringe 97 connectable to the luerlock access 94 or a needled syringe 95 penetrating the angled resealablemember 92 to load the collection chamber 90 with saline.

As further shown in FIG. 9 , once the chamber 90 of the attached vialadapter is fully or partially filled with saline, the vacuum of the vial100 directly pulls the saline 102 through the needle 82 (e.g., a 22gauge needle) into the vial to completely reconstitute the toxin. Then,after such reconstitution, as shown in FIG. 10 , the vial 100 isinverted and the toxin bathes the staggered ports/vents on the needle 82allowing toxin to be pulled into the collection chamber 90, with thefilter 86 preventing particulates from entering the collection chamberwhen drawing up toxin. The toxin in the collection chamber 90 can thenbe drawn out with a luer lock syringe through luer lock 94 or with aneedled syringe through the resealable membrane 92.

Thus, as can be appreciated, the two accesses of the vial adaptersprovide alternatives for the user to inject the saline into the chamberas well as alternatives to withdraw the toxin into the chamber. Note thevial adapters in some embodiments can include only one of the accesses(i.e., either the membrane or luer lock) or other types of accesses.

FIGS. 12-14 illustrate an alternative embodiment of the vial adapter ofthe present invention. The vial adapter 110 provides for passing of adilution fluid into the drug containing vial to reconstitute the drugand provides for passing the reconstituted drug through the vial adapterfor retrieval for injection of the drug into a patient. Thereconstituted drug is passed by application of a vacuum.

More specifically, vial adapter 110 has a side port 112 and a top port114 (as viewed in the orientation of FIG. 12 ). Extending downwardlyfrom the top port 114 is a needle 116 which forms a channel 119 forpassage of dilution fluid such as saline into the vial forreconstitution. Needle 116 can be permanently affixed within adapter 110such as by bonding, although other methods are also contemplated. Theneedle 116 can be attached at a proximal portion 117 to an internalproximal wall 113 of the vial adapter 110. A luer lock with externalthreads 120 is provided at the proximal end of the needle for mountingof a syringe to inject saline for reconstitution. The needle end can beclosed at a proximal end to provide a closed system for vacuum or can beclosed once the syringe is inserted to provide a closed system. Theneedle can include a resealable member at a proximal end for insertionof a needle of syringe 162 to inject saline. At the distal end of theneedle is a penetrating tip 118 for penetrating into the vial (bottle)140 of neurotoxin. The vial 140 includes a chamber 142 for holding theneurotoxin, a rubber stopper 144 and a band or ring 146, e.g., a metalring, circumferentially surrounding the rubber stopper 144 for holdingthe rubber stopper 144 in the vial 140. Thus, the ring 146 is interposedbetween the rubber stopper 144 and the internal wall 152 at the neck 154of the vial 140. The rubber stopper 144 includes a cutaway 148 to allowthe stopper 144 to push out against the exterior. The vial 140 caninclude a peelable tab on its cap that is peeled away to enable accessby the needle through the rubber stopper 144.

The needle 116 can further include a filter adjacent the openings,either inside or outside the needle, to prevent unwanted particles,e.g., pieces of the rubber stopper from the vial, entering the chamber124. Alternatively, or in addition, the openings in the needle can bedimensioned to be small enough so such particles could not pass throughthe openings. Thus, the filters disclosed herein can prevent microparticles from the diluent in the vial entering into the collectionchamber.

The vial adapter 110 further includes a chamber 124 for receiving thediluted neurotoxin, i.e., after reconstitution. The reconstituted drugpasses through the needle 116, chamber 124 and side port 112 asdescribed below. The openings 122, 123 in needle 116 communicate withthe chamber 124, i.e., open into chamber 124. This communication enablesapplication of the vacuum to the vial and suctioning of thereconstituted drug from the vial. Although two openings are shown, it iscontemplated that a different number of openings can be provided. Base126 forms a floor to close off the bottom of the chamber 124. Thechamber 124 is fully enclosed to form a closed system as describedbelow.

Side port 112 is shown transverse to a longitudinal axis of the vialadapter 110 but can alternatively be positioned at other angles. Sideport 112 has a luer lock with external threads 130 for mounting of asyringe to withdraw the neurotoxin from the chamber 124. The luer lockhas a one way valve normally closed to provide a closed system, and asyringe can be inserted through the valve to access the chamber, e.g., amale part of the syringe can open the valve when the syringe isattached. Various types of valves can be utilized such as a penetrablemembrane, leaf valve, etc. Wall 134 provides a stop for the bellows ofthe luer valve. The luer valve side port is attached to the vial adapter110 by bonding, overmolding, or other techniques. With the syringemounted to the luer, channel 115 communicates with the chamber 124.Therefore, the passageway and/or chamber for the vacuum can beconsidered to include this channel. In other forms of mounting, e.g.,extending within the port 112, then the passageway and chamber might beconsidered to only include the chamber 124. Note the needle provides apassage or channel from the vial into the chamber 124 via its openings122, 123.

The use of the vial adapter 110 for drawing neurotoxin from the vial 140will now be described. The vial adapter 110 is attached to the vial 140either removably or permanently. Vial adapter 110 has a bump orprojection 136 at its distal end to grip the vial 140. When attached,the distal penetrating tip of needle 116 penetrates the stopper 144 sothat the tip 118 and its opening 118 a communicate with internal chamber142 of vial 140. A closed system is formed due to the base 126, theinternal wall and the sealed ports 112, 114. A syringe (e.g., syringe162 of FIG. 14A) is then attached to the luer of the needle 116 so it isin communication with the channel (passageway) 119 within needle 116.Upon injection of saline from the syringe, the saline flows throughpassageway 119 exiting opening 118 a to enter the chamber 142 of thevial 140 as it is pulled down due to the vacuum of the vial 140. Withsuch vacuum, the saline enters the chamber 142 of the vial 140 andgenerally does not exit the openings 122, 123 of the needle 116,although in some applications a small amount of saline can enter thechamber 124 of the adapter 110. Note, optionally, initially after thesyringe containing saline is attached, a single squirt can be made toensure flow through the needle 116. The syringe in some embodimentscontains 3 cc of saline, but other amounts are also contemplated.

Once the saline has been mixed with the drug within the vial 140, thesyringe 160 (FIG. 14B), which is attached to the side port 112 (eitherbefore or after attachment of syringe 162 to top port 114), is ready forwithdrawal of the reconstituted (diluted) neurotoxin from the vial 140into the chamber 124 of the vial adapter 110. The vial 140 and vialadapter 110 are inverted (similar to the orientation shown in FIG. 7 )and the syringe 160 is retracted to provide a vacuum force greater thanthe vacuum force of the vial 140 to draw the reconstituted toxin intothe chamber 124 of the vial adapter 110. Note the vacuum is appliedthrough side channel 115, chamber 124, through needle openings 122, 123and needle 116 so the reconstituted toxin enters the distal opening 118a in needle 118 and is drawn through needle passageway 119, out throughopenings 122, 123, into chamber 124 through channel 115 and into thesyringe 160. The syringe 160 in some embodiments has a volume greaterthan the volume in the vial, and could for example hold 10 cc. After thetoxin is drawn from the vial from vial 140, the syringes 160 and 162 canbe removed.

Note in some embodiments, all the toxin from the vial 140 is drawn intothe syringe 160. The toxin can then be drawn from syringe 160 by anothersmaller syringe for injection of the toxin into the patient. In someembodiments, the toxin can be held in the chamber 124 instead of in thesyringe 162. In such embodiments, a vacuum source other than syringe 160can be utilized to communicate with passage 119 to suction the toxininto the chamber 124. In such embodiments, the toxin in the chamber 124could be accessed by insertion of a needle through the side port 112,top port 114 and/or by providing a penetrable membrane as in theembodiment of FIG. 9 .

Note the extra volume syringe 160 and application of the vacuum createsa vortex which can provide additional mixing of the toxin and dilutionliquid. Also, the suction/vacuum can be intermittently broken to allowpassage back into the vial and then back into the chamber/syringe foradditional mixing. To provide an intermittent vacuum, retraction of thesyringe 160 can be controlled, e.g., released (pulled back and forth).Alternatively, a valve or an openable opening can be provided toselectively open the chamber 124 or allow air in to open the otherwiseclosed system.

In the alternate embodiment of FIG. 15 , the adapter 170 is identical toadapter 110 except that the needle 172 does not extend through thechamber 124 as in needle 116 of FIG. 14A. Needle 172 extends from thebase 126 through the rubber stopper 144 and into the vial 140. In thisversion, the saline would be injected into the chamber 124 and thevacuum applied by the chamber 142 of the vial 140 would suction thesaline through the needle 172 and into the chamber 142 of the vial 140.To withdraw the reconstituted toxin, the vacuum through side port 112would draw the toxin through the distal opening 172 a in needle 172,through passage 174 and out proximal opening 176 into chamber 124. Inall other respects, the feature/components and use of the adapter 170 isidentical to adapter 110 so the discussion above for adapter 110 isfully applicable to adapter 170 and like reference numerals are used.

The vial adapter 110 (and other vial adapters disclosed herein) can holdvolumes of diluent volumes ranging from less than 1 cc to 4 cc in volumefor example, although other volumes are also contemplated. Once a luerlocked syringe that is pre-loaded with the desired diluent amount isattached to the vial adapter via the 19 gauge valved port, the adapteris then attached to, e.g., latched onto in some embodiments, a 25 mmvial and that 19 gauge needle gently pierces the rubber stopper of thevacuumed lyophilized vial. The vacuum of the vial draws the diluent fromthe loaded syringe directly into the vial seamlessly, to the point whereall chemically active toxin protein ingredient found within the vial andon its inner walls, in microscopic powder form, is quickly andproficiently reconstituted. In some embodiments, there is no need toshake or swirl the vial in order to ensure proper reconstitution, as thevolume of diluent is completely pulled into the vial with a speed and asubsequent torrent that completely bathes the inside of the vialimmediately. In essence, no nanoparticle of lyophilized microproduct isleft undiluted which produces an ideal, replicable potency of themedicine.

Thus, the vial adapter 110 (and other vial adapters disclosed herein)provides numerous advantages by providing: 1) an easy-to-use,reproducible technique of reconstitution and drawing up neurotoxin usingneedled-syringe access to the vial; 2) sterility of diluting and drawingup neurotoxin; 3) a filtration system which eliminates the risk ofinjecting cored pieces of the rubber stopper into a patient's skin,which presents a risk of infection or intravascular obstruction leadingto a stroke or blindness; and 4) speeds up the process of gettingdiluted toxin out of the vial. The vial adapters also decrease medicalwaste by eliminating the need of using a variety of needles and syringesto dilute and draw up toxin and increase patient satisfaction byeliminating dulling of needled-syringes through the thick rubber stopperwhich is now standard practice.

The vial adapters of the present invention are preferably disposable—forone time use so it can be provided (i.e., bought/discarded) with eachvial.

The vial adapters can include a permanent latching mechanism so thatonce the adapter is attached to a vial it cannot be removed, so as to beone time use.

The vial adapters can be configured to fit different sized vials so thatit can be used beyond the space of neuromodulators and adapt to aspectsof cosmetic injectables. The adapter can be utilized for injection ofbotulinum toxin used for cosmetics such as Botox (sold by Allergan,other brands include Dysport sold by Galderma, Jeaveau sold by Evolus,and Xeomin sold by Merz). Even further, the adapter could be utilized inother fields of medicine, to be integrated into the reconstitutionprocesses of medications such as chemotherapeutics, that also requirereconstitution.

Although the apparatus and methods of the subject disclosure have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentdisclosure as defined by the appended claims.

1-20. (canceled)
 21. A vial adapter for reconstituting a drug anddrawing a drug from a vial, the vial adapter comprising a) a penetratingmember having a penetrating tip configured to extend into the vial toinject a diluent to mix with and reconstitute the drug; b) a chamberdimensioned for containing the reconstituted drug drawn from the vial,the penetrating member in fluid communication with the chamber; c)wherein a vacuum is applied through the adapter to draw thereconstituted drug from the vial into the adapter, the reconstituteddrug drawn through the penetrating member for passage into the chamber.22. The vial adapter of claim 21, further comprising at least a firstport communicating with the chamber to provide access for a syringe todraw the reconstituted drug via vacuum force.
 23. The vial adapter ofclaim 21, wherein the chamber stores the reconstituted drug and isaccessible for subsequent withdrawal of the reconstituted drug therefromfor injection in a patient.
 24. The vial adapter of claim 21, whereinthe penetrating member extends into the chamber.
 25. The vial adapter ofclaim 24, wherein the penetrating member has at least one side openingfor passage of the reconstituted drug into the chamber.
 26. The vialadapter of claim 21, wherein a proximal end of the penetrating member isoutside the chamber.
 27. The vial adapter of claim 22, furthercomprising a second port in fluid communication with the penetratingmember, the second port receiving a syringe for inserting the diluentthrough the adapter and into the vial.
 28. The vial adapter of claim 21,wherein the penetrating member is fixedly attached to a wall of theadapter.
 29. The vial adapter of claim 21, wherein the penetratingmember has a resealable member at a proximal end for insertion of aneedle to inject the diluent, wherein the vial adapter forms a closedsystem to create the vacuum therein for drawing the reconstituted drugfrom the vial and the chamber includes an openable opening toselectively break the vacuum.
 30. A vial adapter for drawing a drug froma vial, the vial adapter comprising a) a penetrating member having apenetrating tip for accessing an internal chamber of the vial containingthe drug, b) a chamber proximal of the penetrating tip, the chamberproviding access for an injection needle to withdraw the drug from thechamber for injection into a patient, the penetrating member both i)providing passage of a diluent into the vial; and ii) subsequentlyproviding passage of the drug after reconstitution into the chamber forsubsequent withdrawal.
 31. The vial adapter of claim 30, wherein asyringe fluidly connected to the chamber withdraws the reconstructeddrug from the chamber.
 32. The vial adapter of claim 30, wherein thepenetrating member forms a vacuum for drawing the reconstituted druginto the chamber.
 33. The vial adapter of claim 30, wherein the chamberincludes one or both of a) a membrane penetrable by an injectionsyringe; and b) an access port for the injection needle.
 34. The vialadapter of claim 30, wherein diluent passes into the vial via vacuumforce.
 35. A method for reconstituting a drug for subsequent injectioninto a patient, the method comprising the steps of a) inserting apenetrating tip of a penetrating member of a vial adapter into a vialcontaining a drug, the vial adapter connected to the vial; b) passing adiluent through the penetrating tip for entry into the vial to mix withand reconstitute the drug; and c) drawing the reconstituted drug fromthe vial into a chamber of the adapter positioned proximal thepenetrating tip.
 36. The method of claim 35, wherein the reconstituteddrug in the chamber is accessible for injection of the drug into apatient by an injection device.
 37. The method of claim 35, wherein thepenetrating tip is entirely distal of the chamber.
 38. The method ofclaim 37, further comprising the step of applying a vacuum through thevial adapter to draw the reconstituted drug from the vial.
 39. Themethod of claim 35, wherein the diluent is inserted via first port ofthe adapter and the reconstituted drug is withdrawn from a second portof the adapter.